Medical Device Manufacturer · US , New York , NY

Siemens Heatlhcare Diagnostics, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2010

Recent clearances: DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL), DIMENSION VISA HBA1C, MODEL K3105A, ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810

View 3 510(k) Devices ↓
3
Total
3
Cleared
0
Denied

FDA 510(k) Regulatory Record - Siemens Heatlhcare Diagnostics, Inc. Chemistry ✕

3 devices
1-3 of 3
Cleared Oct 07, 2011
DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION...
K102772 · OAV
Chemistry · 378d
Cleared Feb 14, 2011
DIMENSION VISA HBA1C, MODEL K3105A
K102045 · LCP
Chemistry · 208d
Cleared Mar 19, 2010
ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810
K100293 · JIT
Chemistry · 45d
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